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CompletedNCT02814773Updated Sep 26, 2016

Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument

An observational study in Dementia, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
310
Ages
65 Years and older
Sex
All
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Study summary

With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and related syndromes are a major public health issue. The lake of drug for treatment or preventing AD, health related quality of life (HRQoL) became an essential criterion of evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally less sensitive for a given disease. That is why other specific tools for AD have been developed. None of them was validated in French. The aim of this study was therefore, after a review of the literature, to achieve a cross-cultural adaptation and psychometric validation of the "Quality of Life in Alzheimer's Disease" (QoL-AD) and "Dementia Quality of Life" (DQoL). These two questionnaires were selected because they were the most popular in English- language literature for this disease.This study concerned a total of 155 patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center. Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have been carried out for these two questionnaires.

Read the detailed description

With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and related syndromes are a major public health issue. The lake of drug for treatment or preventing AD, health related quality of life (HRQoL) became an essential criterion of evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally less sensitive for a given disease. That is why other specific tools for AD have been developed. None of them was validated in French. The aim of this study was therefore, after a review of the literature, to achieve a cross-cultural adaptation and psychometric validation of the "Quality of Life in Alzheimer's Disease" (QoL-AD) and "Dementia Quality of Life" (DQoL). These two questionnaires were selected because they were the most popular in English- language literature for this disease.This study concerned a total of 155 patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center.

Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have been carried out for these two questionnaires. First step: the linguistic adaptation will be performed according to the latest available methodology: that of the " Institute for Work and Health ", as recommended 6 phases. Second step: the psychometric validation will be done after a multicentric study, cross repeated at weekly intervals for the validation phase , with two longitudinal points for the assessment phase of sensitivity to change. Analysis of the results will help define the applicability criteria and psychometric acceptability to know the validity of the adapted instrument that is to say, its content validity , validity of perceived, validity of structure, validity of agreement , its discriminative ability , reliability explored by internal consistency and stability over time. Longitudinal follow-up of patients is expected to also assess the sensitivity to change .

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Conditions studied

  • Dementia

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03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 310 is above the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients included were recruited in centres with a memory clinic or a geriatric ward.

Eligibility criteria

To be included in the study, patients had to be :

  • 65 years or older;
  • native French speakers;
  • living at home or in an institution;
  • suffering from Alzheimer-type dementia defined according to DSM IV criteria, and had to obtain a score of 10 on the MMSE corresponding from mild to moderate dementia
  • to have a main caregiver able to read.

Were not included in the cohort study , patients :

  • From age 65;
  • Achieved an evocative syndrome of dementia is not in accordance with the criteria DSM IV;
  • From a mother tongue other than French;
  • Possessing no help;
  • With a MMSE score \<10 , so with severe dementia;
  • Hospitalized in short , medium or long stay;
  • Having refused to participate in the study .
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
310 participants (actual)
Patient registry
No

Groups and cohorts

  • AD group

    group suffering from Alzheimer-type dementia (mild to moderate dementia)

    Other: questionnaires

Interventions

  • Otherquestionnaires
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What researchers measure

Primary outcomes

  1. The psychometric properties of QoL-AD and DQoL measured by questionnaire

    Time frame: 30 months

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Study locations

1 site
  • Chu Reims
    France, Reims 51092, France
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References and documents

Publications

  • Wolak A, Novella JA, Drame M, Morrone I, Boyer F, Blanchard F, Jolly D. Is the screening test of the French version of the dementia quality of life questionnaire indispensable? Dement Geriatr Cogn Dis Extra. 2011 Jan;1(1):84-92. doi: 10.1159/000326782. Epub 2011 Apr 6. PubMed 22279447 ↗
  • Wolak A, Novella JL, Drame M, Guillemin F, Di Pollina L, Ankri J, Aquino JP, Morrone I, Blanchard F, Jolly D. Transcultural adaptation and psychometric validation of a French-language version of the QoL-AD. Aging Ment Health. 2009 Jul;13(4):593-600. doi: 10.1080/13607860902774386. PubMed 19629785 ↗
  • Barbe C, Morrone I, Wolak-Thierry A, Drame M, Jolly D, Novella JL, Mahmoudi R. Impact of functional alterations on quality of life in patients with Alzheimer's disease. Aging Ment Health. 2017 May;21(5):571-576. doi: 10.1080/13607863.2015.1132674. Epub 2016 Jan 8. PubMed 26745259 ↗
  • Barbe C, Jolly D, Morrone I, Wolak-Thierry A, Drame M, Novella JL, Mahmoudi R. Factors associated with quality of life in patients with Alzheimer's disease. BMC Geriatr. 2018 Jul 9;18(1):159. doi: 10.1186/s12877-018-0855-7. PubMed 29986669 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02814773
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
May 2006
Primary completion
Nov 2008
Completion
Jun 2009
Last update
Sep 26, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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